We support medical device manufacturers across all device classes, from software‑as‑a‑medical‑device (SaMD) to complex implantable technologies. Our translations align with global regulatory frameworks and device‑specific terminology.
Our expertise includes:
- IFUs and user manuals Clear, compliant instructions that meet MDR, IVDR, and FDA requirements.
- Technical documentation Design dossiers, risk management files, and performance evaluation reports.
- Labeling and packaging content UDI‑aligned translations that maintain accuracy across all markets.
- Clinical evaluation reports (CERs) High‑precision translations that support regulatory submissions and audits.
- Software and UI localization SaMD interfaces, digital health platforms, and device‑embedded software.
- Post‑market surveillance documentation Vigilance reports, trend analyses, and safety updates.
Our deep understanding of device‑specific terminology, regulatory frameworks, and technical documentation ensures that every translation is precise, compliant, and ready for global distribution. We help medical device manufacturers bring safe, effective technologies to market worldwide by delivering clear, consistent communication across all product classes and regions.
medicaltranslations.gr 